WO2025085079A1 - Male urine collection devices, related systems and methods - Google Patents
Male urine collection devices, related systems and methods Download PDFInfo
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- WO2025085079A1 WO2025085079A1 PCT/US2023/077205 US2023077205W WO2025085079A1 WO 2025085079 A1 WO2025085079 A1 WO 2025085079A1 US 2023077205 W US2023077205 W US 2023077205W WO 2025085079 A1 WO2025085079 A1 WO 2025085079A1
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- WIPO (PCT)
- Prior art keywords
- chamber
- region
- collection device
- urine collection
- tube
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
- A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Colostomy devices
- A61F5/451—Genital or anal receptacles
- A61F5/453—Genital or anal receptacles for collecting urine or other discharge from male member
Definitions
- An individual may have limited or impaired mobility such that typical urination processes are challenging or impossible.
- the individual may have surgery or a disability that impairs mobility.
- the individual may have restricted travel conditions such as those experienced by pilots, drivers, and workers in hazardous areas. Additionally, fluid collection from the individual may be needed for monitoring purposes or clinical testing.
- Bed pans and urinary catheters such as a Foley catheter
- a Foley catheter can be used to address some of these circumstances.
- bed pans and urinary catheters have several problems associated therewith.
- bed pans can be prone to discomfort, pressure ulcers spills, and other hygiene issues.
- Urinary catheters can be uncomfortable, painful, and can cause urinary tract infections.
- external catheters improve user comfort, leaks may occur due to size of the user, movement of the external catheter, and/or improper placement of the external catheters.
- a urine collection device includes a fluid impermeable barrier, a rim, and an outlet.
- the fluid impermeable barrier has a proximal region, a distal region, and an inner surface defining a chamber therein.
- the rim extends distally from the proximal region into the chamber and at least partially defines an opening sized to receive at least a portion of a penis therethrough. At least some of the rim is spaced inwardly from the inner surface of the fluid impermeable barrier defining the chamber and is sized and configured to form a seal against at least a portion of the penis.
- the chamber is positioned to receive at least some of the penis received through the opening in the proximal region.
- the outlet is in fluid communication with the chamber.
- a urine collection device includes a fluid impermeable barrier, an outlet, and a tube.
- the fluid impermeable barrier defines a chamber and an opening in fluid communication with the chamber.
- the opening is sized to receive at least a portion of a penis therethrough and the chamber is positioned and sized to receive at least some of the penis received through the opening.
- the tube is disposed in the chamber and secured to the outlet such that the tube provides fluid communication between the chamber and the outlet.
- the tube has a tube outlet secured to the outlet of the urine collection device and a tube inlet movable within the chamber while the tube outlet remains in a fixed location.
- a urine collection device includes a fluid impermeable barrier and an outlet.
- the fluid impermeable barrier has a proximal region, an opening in the proximal region sized to receive at least a portion of a penis therethrough, a distal region, and an inner surface defining a chamber.
- the chamber has a proximal shape that widens in the proximal region as the proximal region extends distally towards the distal region and a distal shape in the distal region that widens as the distal region extends proximally towards the proximal region such that the inner surface of the fluid impermeable barrier slopes to include a maximum width of the chamber substantially between the proximal region and the distal region.
- the outlet is in fluid communication with the chamber and is disposed at least proximate to the maximum width of the chamber.
- a system for collecting urine from a user includes any of the fluid (e.g. , urine) collection devices disclosed herein.
- the system also includes a vacuum source configured to apply a vacuum force, a fluid storage container, and at least one conduit connected to the outlet and in fluid communication with the vacuum source and the fluid storage container.
- a method of collecting urine includes inserting a penis of user at least partially through an opening in a urine collection device and into a chamber of the urine collection device.
- the opening and the chamber are at least partially defined by a fluid impermeable barrier of the urine collection device.
- the method includes receiving urine discharged by the user in the chamber.
- the method includes withdrawing the urine from the chamber through a tube having an inlet that is movable within the chamber and through an outlet in the urine collection device.
- FIG. 1A is an isometric proximal view of a fluid collection device, according to an embodiment.
- FIG. IB is an isometric distal view of the fluid collection device of FIG. 1A.
- FIG. 2 is an isometric distal view of a fluid collection device, according to an embodiment.
- FIG. 3 is an isometric distal view of a fluid collection device, according to an embodiment.
- FIG. 4A is an isometric proximal view of a fluid collection device, according to an embodiment.
- FIG. 4B is a cross-sectional side view of the fluid collection device of FIG. 4A, according to an embodiment.
- FIG. 4C is an isometric proximal view of a fluid collection device, according to an embodiment.
- FIG. 5 is a block diagram of a system for fluid collection, according to an embodiment.
- FIG. 6 is a flow diagram of a method to collect fluid, according to an embodiment.
- Embodiments disclosed herein include fluid (e.g., urine) collection devices, and related systems and methods of collecting fluid. Fluid collection devices such as external catheters improve user comfort over conventional internal catheters.
- a fluid collection system includes one or more straps connected to a semi-rigid housing (e.g., fluid collection device or assembly) having an opening for male anatomy (e.g., penis) and a soft (e.g., foam) boot and/or seal area positioned on the housing to seal against the skin of the user.
- the straps are absent (e.g., the straps may be optional).
- the seal area may include a rim extending inward from the opening at least partially into the chamber such that the rim is spaced from the an inner surface of a chamber in the housing.
- the rim extends at least partially around the opening and sized to form a seal against at least a portion of the penis of the user, according to an embodiment.
- the rim includes a flexible rubber configured to press at an angle against the penis, resulting in the technical effect of a tighter seal for the chamber.
- a drainage exit point e.g., outlet
- the inside of the housing e.g., the chamber of the device
- the inside of the housing is shaped such that urine discharged in the chamber is compartmentalized as the urine drains, and urine does not spill back to the opening of the housing.
- the fluid collection device may include a pendulum-type tube (e.g., conduit) positioned in the chamber and in fluid communication with the outlet of the fluid collection device.
- the pendulum-type tube is configured to move within the chamber as the fluid collection device is rotated with the user (e.g., patient) is moved from laying on one side to another.
- This configuration of the pendulum-type tube results in the technical effect of ensuring that the inlet of the tube selfadjusts to be positioned at the low point (e.g. , bottom) of the fluid collection device to effectively pull more fluid from the chamber of the fluid collection device.
- a weight is positioned on the end of the tube near the inlet of the tube. This weight assists in moving the inlet to the low point of the chamber.
- the fluid collection device may include a window to allow viewing of the male anatomy positioned in the chamber of the fluid collection device.
- the window may be concave and/or be configured to magnify the inside of the fluid collection device. This configuration results in the technical effect of allowing a user or caregiver to ensure the male anatomy is responding appropriately to the fluid collection device, a seal is formed against the male anatomy, and/or fluid is being removed properly from the fluid collection device.
- Embodiments of the fluid collection devices disclosed herein are configured to collect fluids from an individual.
- the fluids collected by the fluid collection devices may include urine.
- the fluids collected by the fluid collection devices may also include at least one of penile discharge, reproductive fluids, blood, sweat, or other bodily fluids.
- Embodiments of fluid collection devices disclosed herein may be used in fluid collection systems.
- the fluid collection systems may include a fluid collection device, a fluid storage container, and a portable vacuum source. Fluid (e.g., urine or other bodily fluids) collected in the fluid collection device may be removed from the fluid collection device via a conduit (e.g. tube) which protrudes into an interior region of the fluid collection device.
- a conduit e.g. tube
- a first open end of the conduit may extend into the fluid collection device to a reservoir or chamber therein.
- the second open end of the conduit may extend into the fluid storage container or the portable vacuum source.
- the suction force may be introduced into the interior region of the fluid collection device via the first open end of the conduit responsive to a suction (e.g., vacuum) force applied at the second end of the conduit.
- the suction force may be applied to the second open end of the conduit by the portable vacuum source either directly or indirectly.
- Fluid collection devices described herein may be shaped and sized to be receive at least a portion of a male penis.
- the fluid collection device may include a fluid impermeable barrier at least partially defining a chamber (e.g., interior region of the fluid collection device) of the fluid collection device.
- the fluid impermeable barrier also defines an opening extending therethrough from the external environment.
- the opening may be sized to receive at least a portion of a male penis therethrough to position at least a portion (e.g. , all) of the head of the penis in the chamber.
- Exemplary fluid collection devices for use with the systems and methods herein are described in more detail below.
- the portable vacuum source may be disposed in or on the fluid collection device.
- the conduit may extend from the fluid collection device and attach to the portable vacuum source at a first point therein.
- An additional conduit may attach to the portable vacuum source at a second point thereon and may extend out of the fluid collection device, and may attach to the fluid storage container.
- a vacuum e.g., suction
- Fluid such as urine, may be drained from the fluid collection device using the portable vacuum source.
- FIG. 1A is an isometric proximal view of a fluid collection device 100 and FIG. IB is an isometric distal view of the fluid collection device 100 of FIG. 1A.
- the fluid collection device 100 may include a fluid impermeable barrier 102 having a proximal region 114 and a distal region 124.
- the fluid impermeable barrier 102 also may temporarily store the fluids in a chamber 109 (e.g., interior region) of the fluid impermeable barrier 102.
- the chamber 109 may be an unoccupied portion of the fluid collection device 100 that is void of other material.
- the proximal region 114 and the distal region construction.
- the proximal region 114 and the distal region 124 include two or more materials and/or a multi-piece construction.
- the proximal region 114 and the distal region 124 include different materials and a multi-piece construction.
- the proximal region 114 is secured directly to the distal region 124 with an adhesive, bonding, ultrasonic welding, and/or other mechanical connection configured to form a fluid-tight chamber 109.
- the distal region 124 includes a generally frustoconical shape that narrows distally from the proximal region 114. In some embodiments (not shown), the distal region 124 may be generally semi-spherical or bulbous.
- the distal region 124 may include a semi-rigid material and/or may include an at least partially transparent material.
- distal region 124 may be formed of any suitable fluid impermeable materials, such as a fluid impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, a polycarbonate, etc.), polyurethane films, thermoplastic elastomer (TPE), rubber, thermoplastic polyurethane, another suitable material, or combinations thereof.
- a fluid impermeable polymer e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, a polycarbonate, etc.
- TPE thermoplastic elastomer
- the distal region 124 of the fluid impermeable barrier 102 substantially prevents the fluids from exiting the portions of the chamber 109 that are spaced from the opening 108.
- the distal region 124 of fluid impermeable barrier 102 is flexible, thereby enabling the fluid collection device 100 to bend, curve, or flex during insertion, use, and/or removal of the fluid collection device 100.
- Example fluid impermeable barriers may include, but are not limited to, a fluid impermeable barrier including at least one of Versaflex CL 2000X TPE, Dynaflex G6713 TPE, Silpuran 6000/05 A/B silicone, or Santoprene TPE.
- the distal region 124 of the fluid impermeable barrier 102 may be air permeable.
- the distal region 124 of the fluid impermeable barrier 102 may be formed of a hydrophobic material that defines a plurality of pores.
- one or more portions of at least the outer surface of distal region 124 of the fluid impermeable barrier 102 may be formed from a soft and/or smooth material, thereby reducing chaffing.
- the proximal region 114 includes two or more materials and/or a multi-piece construction.
- the proximal region 114 includes different materials and a multi -piece construction including a foam body 104 and a rim 106.
- the foam body 104 may include a foam ring or other shape secured to the distal region 124.
- the foam body 104 may include a generally circular cross-sectional shape.
- the foam body 104 includes a fluid impermeable foam material.
- the foam body 104 may include an integral skin foam and/or a closed cell foam.
- the foam body 104 may include a skinned ethylene propylene diene monomer (EPDM), neoprene, PVC, skinned open cell foam, and/or unskinned closed cell foam.
- the integral skin foam may include a multilayer polyurethane foam.
- the body of the proximal region 114 includes the same material as the distal region 124.
- the proximal region 114 also may include the rim 106.
- the rim 106 extending distally from the proximal region 114 (e.g., the foam body 104 of the proximal region 114) at least partially into the chamber 109 of the fluid collection device 100 and at least partially e.g., entirely) define an opening 108 sized and dimensioned to receive at least a portion of a penis therethrough.
- the rim 106 and the opening 108 defined by the rim 1086 may be sized and dimensioned to form a seal at least partially (e.g., entirely) around the penis after the penis has been inserted through the opening 108.
- the rim 106 may form a channel extending through the proximal region 114 to the chamber.
- the opening 108 leads into the chamber 109 or interior region of the fluid collection device 100 such that when the penis is inserted through the opening 108, the urethra of the penis is disposed in the chamber 109 of the fluid collection device 100.
- the rim 106 forms a generally frustoconical shape that narrows as the rim 106 extends inward to the chamber 109. Accordingly, the rim 106 may angle inward, thereby allowing the penis to easily be inserted through the opening 108 into the chamber, but also inhibit the penis from sliding out of the fluid collection device 100 without manipulation of the proximal region 114 and the rim 108. In some embodiments, the rim 106 forms a generally cylindrical shape. At least some of the rim 106 may be spaced inwardly from the inner surface of the fluid impermeable barrier 102 that defines the chamber 109.
- the rim 106 defining the opening 108 is closer to a longitudinal axis of the fluid collection device 100 than the inner surface of the fluid impermeable barrier 102 that defines of the chamber 109 proximate to both proximal region 114 and the distal region 424 (the longitudinal axis extending through the opening 108, the proximal region 114, and the distal region 124).
- a track 112 may be disposed in the chamber 109 of the fluid impermeable barrier 102 between the rim 106 and the inner surface of the fluid impermeable barrier 102.
- the track 112 is positioned within the chamber 109 generally in the proximal region 114 of the fluid impermeable barrier 102.
- the track 112 may be defined partially by an inner surface of the foam body 104 and partially by an inner surface of the rim 106.
- the track 112 is generally V- or U-shaped.
- the track 112 may act as a reservoir in the chamber 109 where fluid discharged in the chamber is directed due to the sloped configuration of the distal region 124.
- the rim 106 may include a generally flexible material configured to allow a penis to be inserted therethrough and form a comfortable seal against the penis.
- the rim 106 may include any of the materials of the distal region 124 described above.
- the material of the rim 106 may include polypropylene, polyurethane, high density polyethylene, and/or PVC.
- the rim includes the same material as the distal region 124.
- the proximal region 114 may include a uniform material having a single-piece construction (e.g., the rim 106 and the body of the proximal region 114 are formed of a uniform material).
- the fluid collection device 100 also includes an outlet 116 in fluid communication with the chamber, according to an embodiment.
- the outlet 116 is positioned at the distal region 124 of the of the fluid collection device 100.
- the outlet 116 may be positioned generally opposite to the opening 108.
- the outlet 116 may form a port or other configuration adapted to secure to a conduit in fluid communication with a vacuum source.
- the outlet 116 may narrow as the outlet 116 extends away from the fluid collection device 116, and may be sized be inserted into an inlet of a conduit for a friction fit with the conduit.
- the outlet 116 may extend directly from the distal region 116 of the fluid impermeable barrier 102.
- the distal region includes a distal cap or plate 110 positioned opposite to the proximal region 114.
- the distal cap or plate 110 may be secured to the distal region 110 or formed integrally with the distal region 110 (e.g. , the distal cap or plate 110 includes a material uniform with the distal region 124).
- the distal cap or plate 110 is generally a fluid impermeable material, and may include any of the material described above in relation to the distal region 124 of the fluid impermeable barrier 102.
- the outlet 116 extends or protrudes distally from the distal cap or plate 110.
- the fluid collection device 100 also may include a window 122 disposed in the distal region 124.
- the distal cap or plate 110 may include the window 122.
- the window 122 is generally transparent and allows a user or caregiver to view into the chamber 109 of the fluid impermeable barrier 102 to determine if the penis is positioned properly in the chamber, a seal is formed around the penis (e.g., via the rim 106), the rim 106 is not adversely contacting the penis or cause discomfort or irritation on the penis, and/or the fluid collection device is draining properly.
- the window 122 is generally concave and/or includes material that magnifies the chamber 109 of the fluid impermeable barrier 102 for the viewer.
- the window 122 includes a transparent acrylic, PVC, polycarbonate, and/or polyethylene terephthalate glycol.
- the fluid collection device 100 also may optionally include one or more straps 120 secured to the distal region 124.
- the distal cap or plate 110 may include one or more openings sized to allow the strap 120 to be secured thereto and/or loop therethrough.
- the strap 120 may be sized wrap around the buttocks, hips, and/or waist of the user and hold the proximal region 114 (e.g., the foam body 104) against the user with the penis of the user extending through the rip 106 and the opening 108.
- the strap 120 eliminates the need for adhesives to secure the fluid collection device 100 to the user.
- the fluid collection device 100 also includes a tube 110 disposed in the chamber 109 and secured or securable to the outlet 116 such that the tube 110 provides fluid communication between the chamber 109 and the outlet 116, according to an embodiment.
- the tube 110 may include an outlet secured or securable to the outlet 1 16.
- the tube 110 includes an inlet 111 disposed in the chamber 109 of the fluid impermeable barrier 102.
- the inlet 111 of the tube 110 is disposed in the chamber 109 at least proximate to the rim 106. Accordingly, with the outlet 116 disposed at the distal region 124, the tube 110 may extend proximally from the outlet 116 to the proximal region 114 in the chamber.
- the tube 110 is sized to extend from the outlet 118 and position the inlet 111 in the track 112 between the rim 106 and the foam body 104 of the proximal region 114.
- At least some of the tube 110 may be automatically movable (e.g., self- adjusting) in the chamber 109 responsive movement of the fluid collection device 100, such as when the fluid collection device 100 shifts as a man rotates from laying on his back to laying on his side, or vice versa.
- the tube 110 may be configured such that the inlet 111 moves at least proximate to a low point of the chamber 109 due to gravitational forces.
- the tube 110 may include a weight positioned at least proximate to the inlet 111 of the tube 110 (such as the weight 209 of the fluid collection device 200 shown in FIG. 2).
- the weight may be configured to pull or promote movement of the inlet 111 of the tube at least proximate to the low point of the chamber 109 due to gravitational forces.
- at least some of the tube 110 may be movable within the chamber 109 and the weight may bias the tube inlet 111 to a low point in the chamber.
- the weight may include a coated weight or a weight adhered to the tube 110 proximate to the inlet 111.
- the weight may be metal.
- the weight may be a non-metal weight such that the fluid collection device 100 may be used in an MRI room.
- the weight includes stainless steel, steel, and/or brass.
- the weight may be overmolded with plastic or rubber to prevent corrosion of the weight.
- the weight may be generally cylindrical or frustoconical.
- the tube 110 is configured such that the weight proximate to the inlet 111 bends tube 110 effective to position the inlet at the gravimetrical low point in the chamber 109 and/or track 112.
- the tube 110 may include a flexible material that allows the tube 110 to easily move within the chamber 109 while not collapsing on itself during movement or under a vacuum force.
- the tube 110 includes a flexible silicone, urethane, linear low-density polyethylene, PVC, and/or polyurethane material.
- the tube 110 is secured to or includes a swivel proximate to the outlet that allows for easier movement of the inlet 111 in the chamber.
- the swivel may be configured to allow the tube 1 10 to rotate or pivot within the chamber 109 (e.g. , allow the inlet 111 to move with the track 112), while the port 116 does not rotate or pivot relative to the tube 110.
- the swivel may include a radial bearing or related mechanical swivels.
- the inlet 111 of the tube 110 may be disposed at least partially within the track 112. In these and other embodiments, the inlet 111 of the tube 110 may move around the track 112 to a low point of the track 112 responsive to movement (e.g. , rotation) of the fluid collection device 100.
- a user of the fluid collection device may rotate from his back to his side while wearing the fluid collection device 100.
- the inlet 111 may move within the track 112 to be positioned at low point of the track 112 when the user is on his side.
- the frustoconical or semispherical configuration of the distal region 124 may direct the discharged fluid to the proximal region 114 of the chamber 109 and, more specifically, towards the track 112 in the proximal region 114.
- FIG. 2 is an isometric distal view of a fluid collection device 200, according to an embodiment. Unless otherwise noted, the fluid collection device 200 may include any aspect of the fluid collection device 100.
- the fluid collection device 200 may include a fluid impermeable barrier 202, a proximal region 214, a distal region 224, a foam body 204, a rim 206, an opening 208, a track 212, a distal cap or plate 210, an outlet 216, a tube 210, and a chamber 209 that include any aspect (e.g., materials, shapes, configurations, self-adjusting movements, and/or variations) of the fluid impermeable barrier 102, the proximal region 114, a distal region 124, the foam body 104, the rim 106, the opening 108, the track 112, the distal cap or plate 110, the outlet 116, the tube 110, and/or the chamber 109 of the fluid collection device 100.
- the fluid collection device 200 also includes a weight 209 positioned at least proximate to an inlet (not visible) of the tube 210.
- the weight 209 may include any aspect of the weight described above in relation to the fluid
- the proximal region 214 may include a generally oval cross-section shape, while the rim 206 may be generally cylindrically. This configuration may allow for more available volume in the chamber 209 in certain orientations (shown in the bottom of FIG. 2) where the inlet of the tube 210 will usually be positioned. Nonetheless, the weight 209 biases or moves the inlet of the conduit 1210 at least partially around the track 212 when the fluid collection device 200 is rotated to position the inlet of the tube 210 at the low point of the track 212.
- FIG. 3 is an isometric distal view of a fluid collection device 300, according to an embodiment.
- the fluid collection device 300 may include any aspect of the fluid collection device 100, 200.
- the fluid collection device 300 may include a fluid impermeable barrier 302, a proximal region 314, a distal region 324, a foam body 304, a rim (not visible), an opening (not visible), a track (not visible), an outlet 316, a tube 310, a window 322 and a chamber that include any aspect (e.g., materials, shapes, configurations, self-adjusting movements, and/or variations) of the fluid impermeable barrier 102, the proximal region 114, a distal region 124, the foam body 104, the rim 106/206, the opening 108/208, the track 112, the outlet 116, the tube 110, the weight, and/or the chamber of the fluid collection device 100.
- any aspect e.g., materials, shapes, configurations, self-adjusting movements,
- the fluid impermeable barrier narrows between the second region 315 and the first region 325. In other words, the second region 315 may be wider than the first region 325.
- the tube 310 extends from the outlet 316 in the first region 325 to a tube inlet positioned at least proximate to the second region 315 of the fluid impermeable barrier.
- the proximal region 314 may include an inner surface partially defining the chamber and sloping between the first region 325 and the second region 315 such that the second region
- This configuration of the fluid impermeable barrier 302 may direct fluid discharged in the chamber towards the second region 315 of the fluid impermeable barrier 302 where the inlet of the tube 310 is positioned in the chamber.
- At least some of the tube 310 also may be movable (e.g., self-adjusting) within the chamber as the fluid collection device 300 is rotated.
- the inlet of the tube 310 may self-adjust to the low point of the chamber proximate to the second region 315.
- a weight may be secured to the tube 310 proximate to the tube inlet of the tube 310.
- At least some of the tube 310 may be movable within the chamber and the weight may bias the tube inlet to a low point in the chamber at least proximate to the second region.
- an outlet may be position in the proximal region and a tube may be absent from the chamber of the fluid collection devices.
- FIGS. 4A-4C include examples of fluid collection devices having an outlet positioned in the proximal region and a tube absent from the chamber of the fluid collection devices. It is noted, however, that the fluid collection devices of FIGS. 4A-4C may be modified to position the outlet at the distal region and include a tube extending proximally in the chamber from the outlet to the proximal region.
- FIG. 4A is an isometric proximal view of a fluid collection device 400 and FIG. 4B is a cross-sectional side view of the fluid collection device 400 of FIG. 4A, according to an embodiment.
- the fluid collection device 400 may include any aspect of the fluid collection device 100/200/300.
- the fluid collection device 400 includes a fluid impermeable barrier 402 having a proximal region 414, an opening 408 in the proximal region 414 sized to receive at least a portion of a penis therethrough, a distal region 424, and an inner surface defining a chamber 409.
- the chamber 409 may include a proximal shape that widens in the proximal region as the proximal region extends distally towards the distal region.
- the chamber 409 also may include a distal shape in the distal region that widens as the distal region extends proximally towards the proximal region such that the inner surface of the fluid impermeable barrier 402 slopes to include a maximum width M w of the chamber 409 substantially between the proximal region 414 and the distal region 424.
- at least the interior e.g.
- inner surface) of the proximal region 414 and/or the distal region 424 may include a generally frustoconical and/or semispherical shape that widens towards the maximum width M w of the chamber 409 substantially between the proximal region 414 and the distal region 424.
- both the interior (e.g., inner surface) and the exterior (e.g., outer surface) of the proximal region 414 and/or the distal region 424 may include a generally frustoconical and/or semispherical shape that widens towards the maximum width M w of the chamber 409 substantially between the proximal region 414 and the distal region 424 (e.g., intersection of the proximal region 414 and the distal region 424).
- the proximal region 414 and the distal region 424 of the fluid impermeable barrier 402 include a uniform material having a single-piece construction.
- the proximal region 414 and the distal region 424 include two or more materials and/or a multi-piece construction.
- the proximal region 414 and the distal region 424 include different materials and a multi-piece construction.
- the proximal region 414 is secured directly to the distal region 424 with an adhesive, bonding, ultrasonic welding, and/or other mechanical connection configured to form a fluid-tight chamber 409.
- the distal region 424 may include a semi-rigid material and/or may include an at least partially transparent material. In some embodiments, distal region 424 may be formed of any suitable fluid impermeable materials described above in relation to the distal region 124. In some embodiments, the proximal region 414 includes two or more materials and/or a multi-piece construction. In some embodiments, the proximal region 414 include a single piece proximal region including a uniform material. For example, in the fluid collection device 400, the proximal region 414 includes a single piece construction of a uniform material including a fluid impermeable foam that forms a rim 406 and the outlet 416. In some embodiments, the foam of the proximal region 414 includes any of the foam material described above in relation to the proximal region 114. In some embodiments, the proximal region 414 includes the same material as the distal region 424.
- the proximal region 414 also may include a rim 406 extending distally from the proximal region 414 into the chamber 409 and defining the opening 408 effective to form a channel extending through the proximal region 414 to the chamber 409.
- the rim 406 is spaced inward from at least some of the maximum width M w of the chamber 409, according to an embodiment.
- the rim 406 defining the opening 408 is closer to a longitudinal axis of the fluid collection device 400 than the inner surface of the fluid impermeable barrier 402 at the maximum width of the chamber 409 (the longitudinal axis extending through the opening 458, the proximal region 464, and the distal region 474).
- a width or diameter of the opening 408 and the channel formed by the rim 406 may be less than the maximum width M w of the chamber 409.
- the proximal region 414 also includes a lip 407 extending distally from the rim 406 in the chamber 409.
- the lip 407 may be angled inward and form an enhanced seal around the penis.
- the lip 407 may extend all the way around the channel, or may extend only partially around channel.
- the lip 407 may be disposed proximate to the outlet 416 and may extend only partially around the channel.
- the lip 407 extends about 30° to about 180°, about 30° to about 60°, about 60° to about 90°, about 90° to about 120°, about 120° to about 150°, or about 150° to about 180° around the channel.
- the fluid collection device 400 also includes an outlet 416 in fluid communication with the chamber 409.
- the outlet 416 may include any aspect of the outlets 116/216/316.
- the outlet 416 may be formed of the same material as the rest of the proximal region 414 and/or the distal region 424 in a single piece construction, or may include a separate material secured to the proximal region 414 or the distal region 424.
- the outlet 416 may be disposed at least proximate to the maximum width M w of the chamber 409.
- the outlet 416 is disposed on the proximal region 414 proximate to the maximum width M w of the chamber 409.
- the outlet 416 may be positioned on the distal region 424 proximate to the maximum width M w of the chamber 409. Disposing the outlet 416 at least proximate to the maximum width M w of the chamber 409 positions the outlet 416 in the region of the chamber 409 where fluid 50 (e.g., urine) will be directed after discharge.
- fluid 50 e.g., urine
- the fluid collection device 400 inhibits urine from leaking from the chamber 409.
- the inward spacing of the rim 406 from the maximum width M w of the chamber 409 results in a reservoir in the chamber 409 between the maximum width M w and the rim 406 where the fluid 50 may collect for removal via the outlet 416 positioned at least proximate to the maximum width M w of the chamber 409.
- FIG. 4C is an isometric proximal view of a fluid collection device 450, according to an embodiment.
- the fluid collection device 450 may include any aspect of the fluid collection device 100/200/300/400.
- the fluid collection device 450 includes a fluid impermeable barrier 452 having a proximal region 464, an opening 458 in the proximal region 454 sized to receive at least a portion of a penis therethrough, a distal region 474, and an inner surface defining a chamber 459.
- the chamber 459 may include a proximal shape that widens in the proximal region as the proximal region extends distally towards the distal region.
- the chamber 459 also may include a distal shape in the distal region that widens as the distal region extends proximally towards the proximal region such that the inner surface of the fluid impermeable barrier 452 slopes to include a maximum width of the chamber 459 substantially between the proximal region 464 and the distal region 474.
- At least the interior (e.g., inner surface) of the proximal region 464 and/or the distal region 474 may include a generally frustoconical and/or semispherical shape that widens towards the maximum width of the chamber 459 substantially between the proximal region 454 and the distal region 474.
- outer surface of the proximal region 454 and/or the distal region 474 may include a generally frustoconical and/or semispherical shape that widens towards the maximum width of the chamber 459 substantially between the proximal region 464 and the distal region 474 (e.g., intersection of the proximal region 454 and the distal region 474).
- the proximal region 464 and the distal region 474 of the fluid impermeable barrier 452 include a uniform material having a single-piece construction.
- the proximal region 464 and the distal region 474 include two or more materials and/or a multi-piece construction.
- the proximal region 464 and the distal region 474 include different materials and/or a multi-piece construction.
- the proximal region 464 is secured directly to the distal region 474 with an adhesive, bonding, ultrasonic welding, and/or other mechanical connection configured to form a fluid-tight chamber 459.
- the distal region 474 may include a semi-rigid material and/or may include an at least partially transparent material. In some embodiments, distal region 474 may be formed of any suitable fluid impermeable materials described above in relation to the distal region 124. In some embodiments, the proximal region 464 includes two or more materials and/or a multi-piece construction. In some embodiments, the proximal region 464 include a single piece proximal region including a uniform material. For example, in the fluid collection device 450, the proximal region 464 includes a single piece construction of a uniform material including silicone that also forms the outlet 466. In other embodiments, the proximal region may include a single piece construction of a uniform material other than silicone that also forms the outlet 466.
- the proximal region 464 is thinner than distal region 474.
- the proximal region 464 may be formed in wiper seal configuration that angles inward from the distal region 474 to the opening 458 defined by the proximal region 464.
- the inner periphery 456 of the proximal region 464 defining the opening 458 is spaced inward from the maximum width of the chamber 459.
- the inner periphery 456 defining the opening 458 is closer to a longitudinal axis of the fluid collection device 450 than the inner surface of the fluid impermeable barrier 452 at the maximum width of the chamber 459 (the longitudinal axis extending through the opening 458, the proximal region 464, and the distal region 474).
- the fluid collection device 400 also includes an outlet 466 in fluid communication with the chamber 459.
- the outlet 466 may include any aspect of the outlets 116/216/316/416.
- the outlet 466 may be formed of the same material as the rest of the proximal region 464 and/or the distal region 474 in a single piece construction, or may include a separate material secured to the proximal region 464 or the distal region 474.
- the outlet 466 may be disposed at least proximate to the maximum width of the chamber 459.
- the outlet 466 is disposed on the proximal region 464 proximate to the maximum width of the chamber 459.
- the outlet 466 may be positioned on the distal region 474 proximate to the maximum width of the chamber 459. Disposing the outlet 466 at least proximate to the maximum width of the chamber 459 positions the outlet 466 in the region of the chamber 459 where fluid (e.g., urine) will be directed after discharge.
- the fluid collection device 450 inhibits urine from leaking from the chamber 459.
- the inward spacing of the inner periphery 456 of the proximal region 464 from the maximum width of the chamber 459 results in a reservoir in the chamber 459 between the maximum width and the rim 456 where the fluid may collect for removal via the outlet 466 positioned at least proximate to the maximum width of the chamber 459.
- FIG. 5 is a block diagram of a system 10 for fluid collection, according to an embodiment.
- the system 10 includes a fluid collection device 12, a fluid storage container 14, and a vacuum source 16 (e.g., portable vacuum source).
- the fluid collection device 12 may include any of the fluid collection devices described herein, such as the fluid collection device 100, 200, 300, 400.
- the fluid collection device 12, the fluid storage container 14, and the portable vacuum source 16 may be fluidly coupled to each other via one or more conduits 17.
- the conduit 17 may include any of the conduits described herein, such as the conduit 108.
- the fluid collection device 12 may be operably coupled to one or more of the fluid storage container 14 or the portable vacuum source via the conduit 17.
- Fluid e.g., urine or other bodily fluids collected in the fluid collection device 12 may be removed from the fluid collection device 12 via the conduit 17.
- the second open end of the conduit 17 may extend into the fluid storage container 14 or the portable vacuum source 16.
- the suction force may be introduced into the interior region of the fluid collection device 12 via the first open end of the conduit 17 responsive to a suction (e.g., vacuum) force applied at the second end of the conduit 17.
- the suction force may be applied to the second open end of the conduit 17 by the portable vacuum source 16 either directly or indirectly.
- the suction force may be applied indirectly via the fluid storage container 14.
- the second open end of the conduit 17 may be disposed within the fluid storage container 14 and an additional conduit 17 may extend from the fluid storage container 14 to the portable vacuum source 16.
- the portable vacuum source 16 may apply suction to the fluid collection device 12 via the fluid storage container 14.
- the suction force may be applied directly via the fluid storage container 14.
- the second open end of the conduit 17 may be disposed within the portable vacuum source 16.
- An additional conduit 17 may extend from the portable vacuum source 16 to a point outside of the fluid collection device 12, such as to the fluid storage container 14.
- the portable vacuum source 16 may be disposed between the fluid collection device 12 and the fluid storage container 14.
- the fluid collection device 12 may be shaped and sized to receive at least a portion of the penis of a user.
- the fluid collection member of the fluid collection device 12 may include a fluid impermeable barrier at least partially defining a chamber (e.g., interior region of the fluid collection device member) of the fluid collection device 12.
- Example fluid collection devices for use with the systems and methods herein are described in more detail below.
- the fluid storage container 14 may include a bag (e.g., drainage bag), a bottle or cup (e.g., collection jar), or any other enclosed container for storing bodily fluids such as urine.
- the conduit 17 may extend from the fluid collection device 12 and attach to the fluid storage container 14 at a first point therein.
- An additional conduit 17 may attach to the fluid storage container 14 at a second point thereon and may extend and attach to the portable vacuum source 16.
- the fluid storage container 14 may include a container fluidly coupled to a first conduit section that is also fluidly coupled to the fluid collection member of the fluid collection device 12.
- the container may be fluidly coupled to a second section of the conduit 17 that is also fluidly coupled to a portable vacuum source.
- the portable vacuum source 16 may provide a vacuum/suction through the container to the fluid collection member to provide suction in the chamber of the fluid collection member. Accordingly, a vacuum e.g., suction) may be drawn through fluid collection device 12 via the fluid storage container 14. As the fluid is drained from the chamber, the fluid may travel through the first section of conduit to the fluid storage container where it may be retained. Fluid, such as urine, may be drained from the fluid collection device 12 using the portable vacuum source 16.
- the portable vacuum source 16 may be disposed in or on the fluid collection device 12.
- the conduit 17 may extend from the fluid collection device and attach to the portable vacuum source 16 at a first point therein.
- An additional conduit 17 may attach to the portable vacuum source 16 at a second point thereon and may extend out of the fluid collection device 12, and may attach to the fluid storage container 14. Accordingly, a vacuum (e.g., suction) may be drawn through fluid collection device 12 via the fluid storage container 14.
- a vacuum e.g., suction
- the portable vacuum source 16 may include one or more of a manual vacuum pump, and electric vacuum pump, a diaphragm pump, a centrifugal pump, a displacement pump, a magnetically driven pump, a peristaltic pump, or any pump configured to produce a vacuum.
- the portable vacuum source 16 may provide a vacuum or suction to remove fluid from the fluid collection member of the fluid collection device 12.
- the portable vacuum source 16 may be powered by one or more of a power cord (e.g., connected to a power socket), one or more batteries, or even manual power (e.g., a hand operated vacuum pump).
- the portable vacuum source 16 may be sized and shaped to fit outside of, on, or within the fluid collection device 12.
- the portable vacuum source 16 may include one or more miniaturized pumps or one or more micro pumps.
- the portable vacuum sources 16 disclosed herein may include one or more of a switch, a button, a plug, a remote, or any other device suitable to activate the portable vacuum source 16.
- the portable vacuum sources 16 disclosed herein may provide a portable means of providing a suction or vacuum that allows use of the devices and systems herein outside of hospital or care facility environments where vacuum lines are plumbed into patient rooms or large (e.g., larger or heavier than a patient can readily carry) vacuum sources are located.
- a portable vacuum source may be small and light enough to be carried by a user (e.g., patient) or aid (e.g., nurse) during transportation of the user.
- FIG. 6 is a flow diagram of a method 600 to collect fluid, according to an embodiment.
- the method 600 may utilize any of the fluid collections described herein.
- the method 600 includes an act 605 of inserting a penis of user at least partially through an opening in a urine collection device and into a chamber of the urine collection device.
- the opening and the chamber may be at least partially defined by a fluid impermeable barrier of the urine collection device.
- the method 600 also may include an act 610 of receiving urine discharged by the user in the chamber.
- the method 600 also may include an act 615 of withdrawing the urine from the chamber through a tube having an inlet that is movable within the chamber and through an outlet in the urine collection device.
- the fluid impermeable barrier includes a proximal region defining the opening, a distal region opposite to the proximal region, a first region including the outlet, and a second region opposite to the first region.
- the opening may be positioned between the first region and the second region, and the may extend from the outlet to the tube inlet positioned at least proximate to the second region of the fluid impermeable barrier.
- the proximal region and the distal region may narrow from second region towards the first region.
- the proximal region includes an inner surface partially defining the chamber and sloping between the first region to the second region such that the second region has a greater depth between the proximal region and the distal region than the first region and the urine discharged in the chamber flows to the second region.
- the method 600 also includes an act of biasing the tube inlet to a low point in the chamber at least proximate to the second region with a weight secured to the tube proximate to the tube inlet.
- the act 605 includes inserting the penis of the user through a rim extending distally into the chamber from the proximal region to the chamber such that the rim is spaced inward from the inner surface of the fluid impermeable barrier defining the chamber, with the rim extending around all of the opening and forming a seal against at least a portion of the penis.
- the rim may form a generally frustoconical shape that narrows as the rim extends inward to the chamber.
- the act 605 may include inserting the penis of the user through a rim extending distally at least partially into the chamber from the proximal region to the chamber such that the rim is spaced inward from the inner surface of the fluid impermeable barrier defining the chamber.
- the rim may extend around all of the opening and form a seal against at least a portion of the penis, with the tube inlet being disposed in the chamber at least proximate to the rim.
- the urine collection device includes a track disposed in the chamber between the rim and the inner surface of the fluid impermeable barrier, and the tube inlet may move at least partially within the track to withdraw the urine.
- the method 600 may include an act of biasing the tube inlet to a low point in the chamber with a weight secured to the tube proximate to the tube inlet.
- Acts of the method 600 are for illustrative purposes.
- the acts of the method 600 may be performed in different orders, split into multiple acts, modified, supplemented, or combined. Any of the acts of the method 600 may include using any of the fluid collection devices or systems disclosed herein.
- the term “about” or “substantially” refers to an allowable variance of the term modified by “about” by ⁇ 10% or ⁇ 5%. Further, the terms “less than,” “or less,” “greater than”, “more than,” or “or more” include as an endpoint, the value that is modified by the terms “less than,” “or less,” “greater than,” “more than,” or “or more.” [0074] While various aspects and embodiments have been disclosed herein, other aspects and embodiments are contemplated. The various aspects and embodiment disclosed herein are for purposes of illustration and are not intended to be limiting.
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Abstract
A fluid collection device (100) includes a fluid impermeable barrier (102) having a proximal region (114), a distal region (124), and an inner surface defining a chamber (109) therein. The fluid collection device includes a rim (106) extending distally from the proximal region into the chamber and at least partially defining an opening (108) sized to receive at least a portion of a penis therethrough. At least some of the rim is spaced inwardly from the inner surface of the fluid impermeable barrier defining the chamber and is sized and configured to form a seal against at least a portion of the penis. The chamber is positioned to receive at least some of the penis received through the opening in the proximal region. The fluid collection device includes an outlet (116) in fluid communication with the chamber.
Description
MALE URINE COLLECTION DEVICES, RELATED SYSTEMS AND METHODS
BACKGROUND
[0001] An individual may have limited or impaired mobility such that typical urination processes are challenging or impossible. For example, the individual may have surgery or a disability that impairs mobility. In another example, the individual may have restricted travel conditions such as those experienced by pilots, drivers, and workers in hazardous areas. Additionally, fluid collection from the individual may be needed for monitoring purposes or clinical testing.
[0002] Bed pans and urinary catheters, such as a Foley catheter, can be used to address some of these circumstances. However, bed pans and urinary catheters have several problems associated therewith. For example, bed pans can be prone to discomfort, pressure ulcers spills, and other hygiene issues. Urinary catheters can be uncomfortable, painful, and can cause urinary tract infections. While external catheters improve user comfort, leaks may occur due to size of the user, movement of the external catheter, and/or improper placement of the external catheters.
[0003] Thus, users and manufacturers of fluid collection devices continue to seek new and improved devices, systems, and methods to collect urine.
SUMMARY
[0004] Embodiments disclosed herein are fluid collection devices and related systems and methods are disclosed. In an embodiment, a urine collection device includes a fluid impermeable barrier, a rim, and an outlet. The fluid impermeable barrier has a proximal region, a distal region, and an inner surface defining a chamber therein. The rim extends distally from the proximal region into the chamber and at least partially defines an opening sized to receive at least a portion of a penis therethrough. At least some of the rim is spaced inwardly from the inner surface of the fluid impermeable barrier defining the chamber and is sized and configured to form a seal against at least a portion of the penis. The chamber is positioned to receive at least some of the penis received through the opening in the proximal region. The outlet is in fluid communication with the chamber.
[0005] In an embodiment, a urine collection device includes a fluid impermeable barrier, an outlet, and a tube. The fluid impermeable barrier defines a chamber and an
opening in fluid communication with the chamber. The opening is sized to receive at least a portion of a penis therethrough and the chamber is positioned and sized to receive at least some of the penis received through the opening. The tube is disposed in the chamber and secured to the outlet such that the tube provides fluid communication between the chamber and the outlet. The tube has a tube outlet secured to the outlet of the urine collection device and a tube inlet movable within the chamber while the tube outlet remains in a fixed location.
[0006] In an embodiment, a urine collection device includes a fluid impermeable barrier and an outlet. The fluid impermeable barrier has a proximal region, an opening in the proximal region sized to receive at least a portion of a penis therethrough, a distal region, and an inner surface defining a chamber. The chamber has a proximal shape that widens in the proximal region as the proximal region extends distally towards the distal region and a distal shape in the distal region that widens as the distal region extends proximally towards the proximal region such that the inner surface of the fluid impermeable barrier slopes to include a maximum width of the chamber substantially between the proximal region and the distal region. The outlet is in fluid communication with the chamber and is disposed at least proximate to the maximum width of the chamber.
[0007] In an embodiment, a system for collecting urine from a user is disclosed. The system includes any of the fluid (e.g. , urine) collection devices disclosed herein. The system also includes a vacuum source configured to apply a vacuum force, a fluid storage container, and at least one conduit connected to the outlet and in fluid communication with the vacuum source and the fluid storage container.
[0008] In an embodiment, a method of collecting urine is disclosed. The method includes inserting a penis of user at least partially through an opening in a urine collection device and into a chamber of the urine collection device. The opening and the chamber are at least partially defined by a fluid impermeable barrier of the urine collection device. The method includes receiving urine discharged by the user in the chamber. The method includes withdrawing the urine from the chamber through a tube having an inlet that is movable within the chamber and through an outlet in the urine collection device.
[0009] Features from any of the disclosed embodiments may be used in combination with one another, without limitation. In addition, other features and advantages of the present disclosure will become apparent to those of ordinary skill in the art through consideration of the following detailed description and the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] The drawings illustrate several embodiments of the present disclosure, wherein identical reference numerals refer to identical or similar elements or features in different views or embodiments shown in the drawings.
[0011] FIG. 1A is an isometric proximal view of a fluid collection device, according to an embodiment.
[0012] FIG. IB is an isometric distal view of the fluid collection device of FIG. 1A.
[0013] FIG. 2 is an isometric distal view of a fluid collection device, according to an embodiment.
[0014] FIG. 3 is an isometric distal view of a fluid collection device, according to an embodiment.
[0015] FIG. 4A is an isometric proximal view of a fluid collection device, according to an embodiment.
[0016] FIG. 4B is a cross-sectional side view of the fluid collection device of FIG. 4A, according to an embodiment.
[0017] FIG. 4C is an isometric proximal view of a fluid collection device, according to an embodiment.
[0018] FIG. 5 is a block diagram of a system for fluid collection, according to an embodiment.
[0019] FIG. 6 is a flow diagram of a method to collect fluid, according to an embodiment.
DETAILED DESCRIPTION
[0020] Embodiments disclosed herein include fluid (e.g., urine) collection devices, and related systems and methods of collecting fluid. Fluid collection devices such as external catheters improve user comfort over conventional internal catheters. In at least one, some, or all embodiments disclosed herein, a fluid collection system includes one or more straps connected to a semi-rigid housing (e.g., fluid collection device or assembly) having an opening for male anatomy (e.g., penis) and a soft (e.g., foam) boot and/or seal area positioned on the housing to seal against the skin of the user. In some embodiments, the straps are absent (e.g., the straps may be optional). The seal area may include a rim extending inward from the opening at least partially into the chamber such that the rim is spaced from the an inner surface of a chamber in the housing. The rim extends at least partially around the opening and sized to form a seal against at least a portion of the penis
of the user, according to an embodiment. In at least one, some, or all embodiments, the rim includes a flexible rubber configured to press at an angle against the penis, resulting in the technical effect of a tighter seal for the chamber. In at least one, some, or all embodiments, a drainage exit point (e.g., outlet) is positioned to face downward, and/or may be positioned on at least one of the soft foam and/or the housing. In at least one, some, or all embodiments, disclosed herein, the inside of the housing e.g., the chamber of the device) is shaped such that urine discharged in the chamber is compartmentalized as the urine drains, and urine does not spill back to the opening of the housing. This configuration results in the technical effect of reducing the possibility of leaking of the housing.
[0021] In at least one, some, or all embodiments, the fluid collection device may include a pendulum-type tube (e.g., conduit) positioned in the chamber and in fluid communication with the outlet of the fluid collection device. The pendulum-type tube is configured to move within the chamber as the fluid collection device is rotated with the user (e.g., patient) is moved from laying on one side to another. This configuration of the pendulum-type tube results in the technical effect of ensuring that the inlet of the tube selfadjusts to be positioned at the low point (e.g. , bottom) of the fluid collection device to effectively pull more fluid from the chamber of the fluid collection device. This configuration also results in the technical effect of preventing or inhibiting spills of fluid from the fluid collection device when the patient is on laying on his side. In at least one, some, or all embodiments, a weight is positioned on the end of the tube near the inlet of the tube. This weight assists in moving the inlet to the low point of the chamber.
[0022] In at least one, some, or all embodiments, the fluid collection device may include a window to allow viewing of the male anatomy positioned in the chamber of the fluid collection device. The window may be concave and/or be configured to magnify the inside of the fluid collection device. This configuration results in the technical effect of allowing a user or caregiver to ensure the male anatomy is responding appropriately to the fluid collection device, a seal is formed against the male anatomy, and/or fluid is being removed properly from the fluid collection device.
[0023] Embodiments of the fluid collection devices disclosed herein are configured to collect fluids from an individual. The fluids collected by the fluid collection devices may include urine. The fluids collected by the fluid collection devices may also include at least one of penile discharge, reproductive fluids, blood, sweat, or other bodily fluids. Embodiments of fluid collection devices disclosed herein may be used in fluid collection systems. The fluid collection systems may include a fluid collection device, a fluid storage
container, and a portable vacuum source. Fluid (e.g., urine or other bodily fluids) collected in the fluid collection device may be removed from the fluid collection device via a conduit (e.g. tube) which protrudes into an interior region of the fluid collection device. For example, a first open end of the conduit may extend into the fluid collection device to a reservoir or chamber therein. The second open end of the conduit may extend into the fluid storage container or the portable vacuum source. The suction force may be introduced into the interior region of the fluid collection device via the first open end of the conduit responsive to a suction (e.g., vacuum) force applied at the second end of the conduit. The suction force may be applied to the second open end of the conduit by the portable vacuum source either directly or indirectly.
[0024] Fluid collection devices described herein may be shaped and sized to be receive at least a portion of a male penis. For example, the fluid collection device may include a fluid impermeable barrier at least partially defining a chamber (e.g., interior region of the fluid collection device) of the fluid collection device. The fluid impermeable barrier also defines an opening extending therethrough from the external environment. The opening may be sized to receive at least a portion of a male penis therethrough to position at least a portion (e.g. , all) of the head of the penis in the chamber. Exemplary fluid collection devices for use with the systems and methods herein are described in more detail below.
[0025] In some embodiments, the portable vacuum source may be disposed in or on the fluid collection device. In such embodiments, the conduit may extend from the fluid collection device and attach to the portable vacuum source at a first point therein. An additional conduit may attach to the portable vacuum source at a second point thereon and may extend out of the fluid collection device, and may attach to the fluid storage container. Accordingly, a vacuum (e.g., suction) may be drawn through the fluid collection device via the fluid storage container. Fluid, such as urine, may be drained from the fluid collection device using the portable vacuum source.
[0026] FIG. 1A is an isometric proximal view of a fluid collection device 100 and FIG. IB is an isometric distal view of the fluid collection device 100 of FIG. 1A. The fluid collection device 100 may include a fluid impermeable barrier 102 having a proximal region 114 and a distal region 124. The fluid impermeable barrier 102 also may temporarily store the fluids in a chamber 109 (e.g., interior region) of the fluid impermeable barrier 102. The chamber 109 may be an unoccupied portion of the fluid collection device 100 that is void of other material. In some embodiments, the proximal region 114 and the distal region
construction. In some embodiments, the proximal region 114 and the distal region 124 include two or more materials and/or a multi-piece construction. For example, in the fluid collection device 100, the proximal region 114 and the distal region 124 include different materials and a multi-piece construction. In some embodiments, the proximal region 114 is secured directly to the distal region 124 with an adhesive, bonding, ultrasonic welding, and/or other mechanical connection configured to form a fluid-tight chamber 109. The distal region 124 includes a generally frustoconical shape that narrows distally from the proximal region 114. In some embodiments (not shown), the distal region 124 may be generally semi-spherical or bulbous.
[0027] The distal region 124 may include a semi-rigid material and/or may include an at least partially transparent material. In some embodiments, distal region 124 may be formed of any suitable fluid impermeable materials, such as a fluid impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, a polycarbonate, etc.), polyurethane films, thermoplastic elastomer (TPE), rubber, thermoplastic polyurethane, another suitable material, or combinations thereof. As such, the distal region 124 of the fluid impermeable barrier 102 substantially prevents the fluids from exiting the portions of the chamber 109 that are spaced from the opening 108. The distal region 124 of fluid impermeable barrier 102 is flexible, thereby enabling the fluid collection device 100 to bend, curve, or flex during insertion, use, and/or removal of the fluid collection device 100. Example fluid impermeable barriers may include, but are not limited to, a fluid impermeable barrier including at least one of Versaflex CL 2000X TPE, Dynaflex G6713 TPE, Silpuran 6000/05 A/B silicone, or Santoprene TPE. In an embodiment, the distal region 124 of the fluid impermeable barrier 102 may be air permeable. In such an embodiment, the distal region 124 of the fluid impermeable barrier 102 may be formed of a hydrophobic material that defines a plurality of pores. In an embodiment, one or more portions of at least the outer surface of distal region 124 of the fluid impermeable barrier 102 may be formed from a soft and/or smooth material, thereby reducing chaffing.
[0028] In some embodiments, the proximal region 114 includes two or more materials and/or a multi-piece construction. For example, in the fluid collection device 100, the proximal region 114 includes different materials and a multi -piece construction including a foam body 104 and a rim 106. The foam body 104 may include a foam ring or other shape secured to the distal region 124. In some embodiments, the foam body 104 may include a generally circular cross-sectional shape. In some embodiments, the foam body 104 includes a fluid impermeable foam material. For example, the foam body 104 may
include an integral skin foam and/or a closed cell foam. In some embodiments, the foam body 104 may include a skinned ethylene propylene diene monomer (EPDM), neoprene, PVC, skinned open cell foam, and/or unskinned closed cell foam. The integral skin foam may include a multilayer polyurethane foam. In some embodiments, the body of the proximal region 114 includes the same material as the distal region 124.
[0029] The proximal region 114 also may include the rim 106. The rim 106 extending distally from the proximal region 114 (e.g., the foam body 104 of the proximal region 114) at least partially into the chamber 109 of the fluid collection device 100 and at least partially e.g., entirely) define an opening 108 sized and dimensioned to receive at least a portion of a penis therethrough. Accordingly, the rim 106 and the opening 108 defined by the rim 1086 may be sized and dimensioned to form a seal at least partially (e.g., entirely) around the penis after the penis has been inserted through the opening 108. In embodiments having the rim 106 extending around all of and/or define all of the opening 108, the rim 106 may form a channel extending through the proximal region 114 to the chamber. The opening 108 leads into the chamber 109 or interior region of the fluid collection device 100 such that when the penis is inserted through the opening 108, the urethra of the penis is disposed in the chamber 109 of the fluid collection device 100.
[0030] In some embodiments, the rim 106 forms a generally frustoconical shape that narrows as the rim 106 extends inward to the chamber 109. Accordingly, the rim 106 may angle inward, thereby allowing the penis to easily be inserted through the opening 108 into the chamber, but also inhibit the penis from sliding out of the fluid collection device 100 without manipulation of the proximal region 114 and the rim 108. In some embodiments, the rim 106 forms a generally cylindrical shape. At least some of the rim 106 may be spaced inwardly from the inner surface of the fluid impermeable barrier 102 that defines the chamber 109. In other words, the rim 106 defining the opening 108 is closer to a longitudinal axis of the fluid collection device 100 than the inner surface of the fluid impermeable barrier 102 that defines of the chamber 109 proximate to both proximal region 114 and the distal region 424 (the longitudinal axis extending through the opening 108, the proximal region 114, and the distal region 124). For example, a track 112 may be disposed in the chamber 109 of the fluid impermeable barrier 102 between the rim 106 and the inner surface of the fluid impermeable barrier 102. In some embodiments, the track 112 is positioned within the chamber 109 generally in the proximal region 114 of the fluid impermeable barrier 102. Accordingly, the track 112 may be defined partially by an inner surface of the foam body 104 and partially by an inner surface of the rim 106. In some
embodiments, the track 112 is generally V- or U-shaped. The track 112 may act as a reservoir in the chamber 109 where fluid discharged in the chamber is directed due to the sloped configuration of the distal region 124.
[0031] The rim 106 may include a generally flexible material configured to allow a penis to be inserted therethrough and form a comfortable seal against the penis. The rim 106 may include any of the materials of the distal region 124 described above. In some embodiments, the material of the rim 106 may include polypropylene, polyurethane, high density polyethylene, and/or PVC. In some embodiments, the rim includes the same material as the distal region 124. In some embodiments, the proximal region 114 may include a uniform material having a single-piece construction (e.g., the rim 106 and the body of the proximal region 114 are formed of a uniform material).
[0032] The fluid collection device 100 also includes an outlet 116 in fluid communication with the chamber, according to an embodiment. In some embodiments, the outlet 116 is positioned at the distal region 124 of the of the fluid collection device 100. For example, the outlet 116 may be positioned generally opposite to the opening 108. The outlet 116 may form a port or other configuration adapted to secure to a conduit in fluid communication with a vacuum source. For example, the outlet 116 may narrow as the outlet 116 extends away from the fluid collection device 116, and may be sized be inserted into an inlet of a conduit for a friction fit with the conduit.
[0033] The outlet 116 may extend directly from the distal region 116 of the fluid impermeable barrier 102. In some embodiments, the distal region includes a distal cap or plate 110 positioned opposite to the proximal region 114. The distal cap or plate 110 may be secured to the distal region 110 or formed integrally with the distal region 110 (e.g. , the distal cap or plate 110 includes a material uniform with the distal region 124). The distal cap or plate 110 is generally a fluid impermeable material, and may include any of the material described above in relation to the distal region 124 of the fluid impermeable barrier 102. In some embodiments the outlet 116 extends or protrudes distally from the distal cap or plate 110.
[0034] The fluid collection device 100 also may include a window 122 disposed in the distal region 124. For example, the distal cap or plate 110 may include the window 122. The window 122 is generally transparent and allows a user or caregiver to view into the chamber 109 of the fluid impermeable barrier 102 to determine if the penis is positioned properly in the chamber, a seal is formed around the penis (e.g., via the rim 106), the rim 106 is not adversely contacting the penis or cause discomfort or irritation on the penis,
and/or the fluid collection device is draining properly. In some embodiments, the window 122 is generally concave and/or includes material that magnifies the chamber 109 of the fluid impermeable barrier 102 for the viewer. In some embodiments, the window 122 includes a transparent acrylic, PVC, polycarbonate, and/or polyethylene terephthalate glycol.
[0035] In some embodiments, the fluid collection device 100 also may optionally include one or more straps 120 secured to the distal region 124. For example, the distal cap or plate 110 may include one or more openings sized to allow the strap 120 to be secured thereto and/or loop therethrough. The strap 120 may be sized wrap around the buttocks, hips, and/or waist of the user and hold the proximal region 114 (e.g., the foam body 104) against the user with the penis of the user extending through the rip 106 and the opening 108. In some embodiments, the strap 120 eliminates the need for adhesives to secure the fluid collection device 100 to the user.
[0036] The fluid collection device 100 also includes a tube 110 disposed in the chamber 109 and secured or securable to the outlet 116 such that the tube 110 provides fluid communication between the chamber 109 and the outlet 116, according to an embodiment. For example, the tube 110 may include an outlet secured or securable to the outlet 1 16. The tube 110 includes an inlet 111 disposed in the chamber 109 of the fluid impermeable barrier 102. In some embodiments, the inlet 111 of the tube 110 is disposed in the chamber 109 at least proximate to the rim 106. Accordingly, with the outlet 116 disposed at the distal region 124, the tube 110 may extend proximally from the outlet 116 to the proximal region 114 in the chamber. In some embodiments, the tube 110 is sized to extend from the outlet 118 and position the inlet 111 in the track 112 between the rim 106 and the foam body 104 of the proximal region 114.
[0037] At least some of the tube 110 may be automatically movable (e.g., self- adjusting) in the chamber 109 responsive movement of the fluid collection device 100, such as when the fluid collection device 100 shifts as a man rotates from laying on his back to laying on his side, or vice versa. For example, the tube 110 may be configured such that the inlet 111 moves at least proximate to a low point of the chamber 109 due to gravitational forces. In some embodiments, the tube 110 may include a weight positioned at least proximate to the inlet 111 of the tube 110 (such as the weight 209 of the fluid collection device 200 shown in FIG. 2). The weight may be configured to pull or promote movement of the inlet 111 of the tube at least proximate to the low point of the chamber 109 due to gravitational forces. In other words, at least some of the tube 110 may be movable within
the chamber 109 and the weight may bias the tube inlet 111 to a low point in the chamber. The weight may include a coated weight or a weight adhered to the tube 110 proximate to the inlet 111. In some embodiments, the weight may be metal. In some embodiments, the weight may be a non-metal weight such that the fluid collection device 100 may be used in an MRI room. In some embodiments, the weight includes stainless steel, steel, and/or brass. In some embodiments, the weight may be overmolded with plastic or rubber to prevent corrosion of the weight. In some embodiments, the weight may be generally cylindrical or frustoconical.
[0038] In some embodiments, the tube 110 is configured such that the weight proximate to the inlet 111 bends tube 110 effective to position the inlet at the gravimetrical low point in the chamber 109 and/or track 112. The tube 110 may include a flexible material that allows the tube 110 to easily move within the chamber 109 while not collapsing on itself during movement or under a vacuum force. In some embodiments, the tube 110 includes a flexible silicone, urethane, linear low-density polyethylene, PVC, and/or polyurethane material. In some embodiments, the tube 110 is secured to or includes a swivel proximate to the outlet that allows for easier movement of the inlet 111 in the chamber. The swivel may be configured to allow the tube 1 10 to rotate or pivot within the chamber 109 (e.g. , allow the inlet 111 to move with the track 112), while the port 116 does not rotate or pivot relative to the tube 110. For example, the swivel may include a radial bearing or related mechanical swivels. The inlet 111 of the tube 110 may be disposed at least partially within the track 112. In these and other embodiments, the inlet 111 of the tube 110 may move around the track 112 to a low point of the track 112 responsive to movement (e.g. , rotation) of the fluid collection device 100.
[0039] In an example use of the fluid collection device 100, a user of the fluid collection device may rotate from his back to his side while wearing the fluid collection device 100. As the user rotates, the inlet 111 may move within the track 112 to be positioned at low point of the track 112 when the user is on his side. When the user discharges fluid (e.g., urine), even on his side, the frustoconical or semispherical configuration of the distal region 124 may direct the discharged fluid to the proximal region 114 of the chamber 109 and, more specifically, towards the track 112 in the proximal region 114. With the inlet 111 of the tube 110 positioned at the low point of the chamber 109 and/or track 112, substantially all of the fluid may be pulled from the chamber 109 through the inlet 111 when a vacuum force is applied to the outlet 118 (e.g., via a conduit secured to the outlet 118).
[0040] FIG. 2 is an isometric distal view of a fluid collection device 200, according to an embodiment. Unless otherwise noted, the fluid collection device 200 may include any aspect of the fluid collection device 100. For example, unless otherwise noted, the fluid collection device 200 may include a fluid impermeable barrier 202, a proximal region 214, a distal region 224, a foam body 204, a rim 206, an opening 208, a track 212, a distal cap or plate 210, an outlet 216, a tube 210, and a chamber 209 that include any aspect (e.g., materials, shapes, configurations, self-adjusting movements, and/or variations) of the fluid impermeable barrier 102, the proximal region 114, a distal region 124, the foam body 104, the rim 106, the opening 108, the track 112, the distal cap or plate 110, the outlet 116, the tube 110, and/or the chamber 109 of the fluid collection device 100. The fluid collection device 200 also includes a weight 209 positioned at least proximate to an inlet (not visible) of the tube 210. The weight 209 may include any aspect of the weight described above in relation to the fluid collection device 100.
[0041] In some embodiments of the fluid collection device 200, the proximal region 214 may include a generally oval cross-section shape, while the rim 206 may be generally cylindrically. This configuration may allow for more available volume in the chamber 209 in certain orientations (shown in the bottom of FIG. 2) where the inlet of the tube 210 will usually be positioned. Nonetheless, the weight 209 biases or moves the inlet of the conduit 1210 at least partially around the track 212 when the fluid collection device 200 is rotated to position the inlet of the tube 210 at the low point of the track 212.
[0042] FIG. 3 is an isometric distal view of a fluid collection device 300, according to an embodiment. Unless otherwise noted, the fluid collection device 300 may include any aspect of the fluid collection device 100, 200. For example, unless otherwise noted, the fluid collection device 300 may include a fluid impermeable barrier 302, a proximal region 314, a distal region 324, a foam body 304, a rim (not visible), an opening (not visible), a track (not visible), an outlet 316, a tube 310, a window 322 and a chamber that include any aspect (e.g., materials, shapes, configurations, self-adjusting movements, and/or variations) of the fluid impermeable barrier 102, the proximal region 114, a distal region 124, the foam body 104, the rim 106/206, the opening 108/208, the track 112, the outlet 116, the tube 110, the weight, and/or the chamber of the fluid collection device 100.
[0043] In some embodiments of the fluid collection device 300, the fluid impermeable barrier 302 includes the proximal region 314, the distal region 324 opposite to the proximal region, a first region 325 including the outlet, and a second region 315 opposite to the first region 325. The opening (not visible) in the proximal region 314 may be positioned
between the first region 325 and the second region 315. For example, the fluid collection device 300 may include rim similar to the rim 106 or the rim 206 in the proximal region
314 of the fluid impermeable barrier 302. In some embodiments, the fluid impermeable barrier narrows between the second region 315 and the first region 325. In other words, the second region 315 may be wider than the first region 325.
[0044] In some embodiments of the fluid collection device 300, the tube 310 extends from the outlet 316 in the first region 325 to a tube inlet positioned at least proximate to the second region 315 of the fluid impermeable barrier. In these and other embodiments, the proximal region 314 may include an inner surface partially defining the chamber and sloping between the first region 325 and the second region 315 such that the second region
315 has a greater depth between the proximal region 314 and the distal region 324 than the first region 325. This configuration of the fluid impermeable barrier 302 may direct fluid discharged in the chamber towards the second region 315 of the fluid impermeable barrier 302 where the inlet of the tube 310 is positioned in the chamber.
[0045] At least some of the tube 310 also may be movable (e.g., self-adjusting) within the chamber as the fluid collection device 300 is rotated. For example, similar to the tubes 1 10, 210, the inlet of the tube 310 may self-adjust to the low point of the chamber proximate to the second region 315. In some embodiments, a weight may be secured to the tube 310 proximate to the tube inlet of the tube 310. At least some of the tube 310 may be movable within the chamber and the weight may bias the tube inlet to a low point in the chamber at least proximate to the second region.
[0046] In some embodiments of fluid collection devices disclosed herein, an outlet may be position in the proximal region and a tube may be absent from the chamber of the fluid collection devices. FIGS. 4A-4C include examples of fluid collection devices having an outlet positioned in the proximal region and a tube absent from the chamber of the fluid collection devices. It is noted, however, that the fluid collection devices of FIGS. 4A-4C may be modified to position the outlet at the distal region and include a tube extending proximally in the chamber from the outlet to the proximal region.
[0047] FIG. 4A is an isometric proximal view of a fluid collection device 400 and FIG. 4B is a cross-sectional side view of the fluid collection device 400 of FIG. 4A, according to an embodiment. Unless otherwise noted, the fluid collection device 400 may include any aspect of the fluid collection device 100/200/300. The fluid collection device 400 includes a fluid impermeable barrier 402 having a proximal region 414, an opening 408 in the
proximal region 414 sized to receive at least a portion of a penis therethrough, a distal region 424, and an inner surface defining a chamber 409.
[0048] The chamber 409 may include a proximal shape that widens in the proximal region as the proximal region extends distally towards the distal region. The chamber 409 also may include a distal shape in the distal region that widens as the distal region extends proximally towards the proximal region such that the inner surface of the fluid impermeable barrier 402 slopes to include a maximum width Mw of the chamber 409 substantially between the proximal region 414 and the distal region 424. In some embodiments, at least the interior (e.g. , inner surface) of the proximal region 414 and/or the distal region 424 may include a generally frustoconical and/or semispherical shape that widens towards the maximum width Mw of the chamber 409 substantially between the proximal region 414 and the distal region 424. In some embodiments, both the interior (e.g., inner surface) and the exterior (e.g., outer surface) of the proximal region 414 and/or the distal region 424 may include a generally frustoconical and/or semispherical shape that widens towards the maximum width Mw of the chamber 409 substantially between the proximal region 414 and the distal region 424 (e.g., intersection of the proximal region 414 and the distal region 424).
[0049] In some embodiments, the proximal region 414 and the distal region 424 of the fluid impermeable barrier 402 include a uniform material having a single-piece construction. In some embodiments, the proximal region 414 and the distal region 424 include two or more materials and/or a multi-piece construction. For example, in the fluid collection device 400, the proximal region 414 and the distal region 424 include different materials and a multi-piece construction. In some embodiments, the proximal region 414 is secured directly to the distal region 424 with an adhesive, bonding, ultrasonic welding, and/or other mechanical connection configured to form a fluid-tight chamber 409.
[0050] The distal region 424 may include a semi-rigid material and/or may include an at least partially transparent material. In some embodiments, distal region 424 may be formed of any suitable fluid impermeable materials described above in relation to the distal region 124. In some embodiments, the proximal region 414 includes two or more materials and/or a multi-piece construction. In some embodiments, the proximal region 414 include a single piece proximal region including a uniform material. For example, in the fluid collection device 400, the proximal region 414 includes a single piece construction of a uniform material including a fluid impermeable foam that forms a rim 406 and the outlet 416. In some embodiments, the foam of the proximal region 414 includes any of the foam
material described above in relation to the proximal region 114. In some embodiments, the proximal region 414 includes the same material as the distal region 424.
[0051] The proximal region 414 also may include a rim 406 extending distally from the proximal region 414 into the chamber 409 and defining the opening 408 effective to form a channel extending through the proximal region 414 to the chamber 409. The rim 406 is spaced inward from at least some of the maximum width Mw of the chamber 409, according to an embodiment. In other words, the rim 406 defining the opening 408 is closer to a longitudinal axis of the fluid collection device 400 than the inner surface of the fluid impermeable barrier 402 at the maximum width of the chamber 409 (the longitudinal axis extending through the opening 458, the proximal region 464, and the distal region 474). Accordingly, a width or diameter of the opening 408 and the channel formed by the rim 406 may be less than the maximum width Mw of the chamber 409. In some embodiments, the proximal region 414 also includes a lip 407 extending distally from the rim 406 in the chamber 409. The lip 407 may be angled inward and form an enhanced seal around the penis. The lip 407 may extend all the way around the channel, or may extend only partially around channel. For example, the lip 407 may be disposed proximate to the outlet 416 and may extend only partially around the channel. In some embodiments, the lip 407 extends about 30° to about 180°, about 30° to about 60°, about 60° to about 90°, about 90° to about 120°, about 120° to about 150°, or about 150° to about 180° around the channel.
[0052] The fluid collection device 400 also includes an outlet 416 in fluid communication with the chamber 409. Unless otherwise noted, the outlet 416 may include any aspect of the outlets 116/216/316. The outlet 416 may be formed of the same material as the rest of the proximal region 414 and/or the distal region 424 in a single piece construction, or may include a separate material secured to the proximal region 414 or the distal region 424.
[0053] The outlet 416 may be disposed at least proximate to the maximum width Mw of the chamber 409. In the fluid collection device 400, the outlet 416 is disposed on the proximal region 414 proximate to the maximum width Mw of the chamber 409. In some embodiments (not shown), the outlet 416 may be positioned on the distal region 424 proximate to the maximum width Mwof the chamber 409. Disposing the outlet 416 at least proximate to the maximum width Mw of the chamber 409 positions the outlet 416 in the region of the chamber 409 where fluid 50 (e.g., urine) will be directed after discharge. For example, because the inner surface of the fluid impermeable barrier 402 slopes to the maximum width Mwof the chamber 409, gravity pulls the fluid 50 to the outlet 416 disposed
at least proximate to the maximum width Mw of the chamber 409. Furthermore, because the rim 406 is spaced inwardly from the maximum width Mw of the chamber 409, the fluid collection device 400 inhibits urine from leaking from the chamber 409. For example, the inward spacing of the rim 406 from the maximum width Mw of the chamber 409 results in a reservoir in the chamber 409 between the maximum width Mw and the rim 406 where the fluid 50 may collect for removal via the outlet 416 positioned at least proximate to the maximum width Mw of the chamber 409.
[0054] FIG. 4C is an isometric proximal view of a fluid collection device 450, according to an embodiment. Unless otherwise noted, the fluid collection device 450 may include any aspect of the fluid collection device 100/200/300/400. The fluid collection device 450 includes a fluid impermeable barrier 452 having a proximal region 464, an opening 458 in the proximal region 454 sized to receive at least a portion of a penis therethrough, a distal region 474, and an inner surface defining a chamber 459.
[0055] The chamber 459 may include a proximal shape that widens in the proximal region as the proximal region extends distally towards the distal region. The chamber 459 also may include a distal shape in the distal region that widens as the distal region extends proximally towards the proximal region such that the inner surface of the fluid impermeable barrier 452 slopes to include a maximum width of the chamber 459 substantially between the proximal region 464 and the distal region 474. In some embodiments, at least the interior (e.g., inner surface) of the proximal region 464 and/or the distal region 474 may include a generally frustoconical and/or semispherical shape that widens towards the maximum width of the chamber 459 substantially between the proximal region 454 and the distal region 474. In some embodiments, both the interior (e.g., inner surface) and the exterior (e.g. , outer surface) of the proximal region 454 and/or the distal region 474 may include a generally frustoconical and/or semispherical shape that widens towards the maximum width of the chamber 459 substantially between the proximal region 464 and the distal region 474 (e.g., intersection of the proximal region 454 and the distal region 474).
[0056] In some embodiments, the proximal region 464 and the distal region 474 of the fluid impermeable barrier 452 include a uniform material having a single-piece construction. In some embodiments, the proximal region 464 and the distal region 474 include two or more materials and/or a multi-piece construction. For example, in the fluid collection device 450, the proximal region 464 and the distal region 474 include different materials and/or a multi-piece construction. In some embodiments, the proximal region
464 is secured directly to the distal region 474 with an adhesive, bonding, ultrasonic welding, and/or other mechanical connection configured to form a fluid-tight chamber 459. [0057] The distal region 474 may include a semi-rigid material and/or may include an at least partially transparent material. In some embodiments, distal region 474 may be formed of any suitable fluid impermeable materials described above in relation to the distal region 124. In some embodiments, the proximal region 464 includes two or more materials and/or a multi-piece construction. In some embodiments, the proximal region 464 include a single piece proximal region including a uniform material. For example, in the fluid collection device 450, the proximal region 464 includes a single piece construction of a uniform material including silicone that also forms the outlet 466. In other embodiments, the proximal region may include a single piece construction of a uniform material other than silicone that also forms the outlet 466.
[0058] In many embodiments, the proximal region 464 is thinner than distal region 474. For example, the proximal region 464 may be formed in wiper seal configuration that angles inward from the distal region 474 to the opening 458 defined by the proximal region 464. As the proximal region 464 may extend inward from the distal region 474 towards the opening 458, the inner periphery 456 of the proximal region 464 defining the opening 458 is spaced inward from the maximum width of the chamber 459. In other words, the inner periphery 456 defining the opening 458 is closer to a longitudinal axis of the fluid collection device 450 than the inner surface of the fluid impermeable barrier 452 at the maximum width of the chamber 459 (the longitudinal axis extending through the opening 458, the proximal region 464, and the distal region 474).
[0059] The fluid collection device 400 also includes an outlet 466 in fluid communication with the chamber 459. Unless otherwise noted, the outlet 466 may include any aspect of the outlets 116/216/316/416. The outlet 466 may be formed of the same material as the rest of the proximal region 464 and/or the distal region 474 in a single piece construction, or may include a separate material secured to the proximal region 464 or the distal region 474.
[0060] The outlet 466 may be disposed at least proximate to the maximum width of the chamber 459. In the fluid collection device 450, the outlet 466 is disposed on the proximal region 464 proximate to the maximum width of the chamber 459. In some embodiments (not shown), the outlet 466 may be positioned on the distal region 474 proximate to the maximum width of the chamber 459. Disposing the outlet 466 at least proximate to the maximum width of the chamber 459 positions the outlet 466 in the region of the chamber
459 where fluid (e.g., urine) will be directed after discharge. For example, because the inner surface of the fluid impermeable barrier 452 slopes to the maximum width of the chamber 459, gravity pulls the fluid to the outlet 466 disposed at least proximate to the maximum width of the chamber 459. Furthermore, because the inner periphery 456 of the proximal region 464 is spaced inwardly from the maximum width of the chamber 459, the fluid collection device 450 inhibits urine from leaking from the chamber 459. For example, the inward spacing of the inner periphery 456 of the proximal region 464 from the maximum width of the chamber 459 results in a reservoir in the chamber 459 between the maximum width and the rim 456 where the fluid may collect for removal via the outlet 466 positioned at least proximate to the maximum width of the chamber 459.
[0061] FIG. 5 is a block diagram of a system 10 for fluid collection, according to an embodiment. The system 10 includes a fluid collection device 12, a fluid storage container 14, and a vacuum source 16 (e.g., portable vacuum source). The fluid collection device 12 may include any of the fluid collection devices described herein, such as the fluid collection device 100, 200, 300, 400. The fluid collection device 12, the fluid storage container 14, and the portable vacuum source 16 may be fluidly coupled to each other via one or more conduits 17. The conduit 17 may include any of the conduits described herein, such as the conduit 108. The fluid collection device 12 may be operably coupled to one or more of the fluid storage container 14 or the portable vacuum source via the conduit 17. Fluid (e.g., urine or other bodily fluids) collected in the fluid collection device 12 may be removed from the fluid collection device 12 via the conduit 17. The second open end of the conduit 17 may extend into the fluid storage container 14 or the portable vacuum source 16. The suction force may be introduced into the interior region of the fluid collection device 12 via the first open end of the conduit 17 responsive to a suction (e.g., vacuum) force applied at the second end of the conduit 17. The suction force may be applied to the second open end of the conduit 17 by the portable vacuum source 16 either directly or indirectly.
[0062] The suction force may be applied indirectly via the fluid storage container 14. For example, the second open end of the conduit 17 may be disposed within the fluid storage container 14 and an additional conduit 17 may extend from the fluid storage container 14 to the portable vacuum source 16. Accordingly, the portable vacuum source 16 may apply suction to the fluid collection device 12 via the fluid storage container 14. The suction force may be applied directly via the fluid storage container 14. For example, the second open end of the conduit 17 may be disposed within the portable vacuum source 16. An additional conduit 17 may extend from the portable vacuum source 16 to a point
outside of the fluid collection device 12, such as to the fluid storage container 14. In such examples, the portable vacuum source 16 may be disposed between the fluid collection device 12 and the fluid storage container 14.
[0063] The fluid collection device 12 may be shaped and sized to receive at least a portion of the penis of a user. The fluid collection member of the fluid collection device 12 may include a fluid impermeable barrier at least partially defining a chamber (e.g., interior region of the fluid collection device member) of the fluid collection device 12. Example fluid collection devices for use with the systems and methods herein are described in more detail below.
[0064] In some embodiments, the fluid storage container 14 may include a bag (e.g., drainage bag), a bottle or cup (e.g., collection jar), or any other enclosed container for storing bodily fluids such as urine. In examples, the conduit 17 may extend from the fluid collection device 12 and attach to the fluid storage container 14 at a first point therein. An additional conduit 17 may attach to the fluid storage container 14 at a second point thereon and may extend and attach to the portable vacuum source 16. For example, the fluid storage container 14 may include a container fluidly coupled to a first conduit section that is also fluidly coupled to the fluid collection member of the fluid collection device 12. The container may be fluidly coupled to a second section of the conduit 17 that is also fluidly coupled to a portable vacuum source. In such examples, the portable vacuum source 16 may provide a vacuum/suction through the container to the fluid collection member to provide suction in the chamber of the fluid collection member. Accordingly, a vacuum e.g., suction) may be drawn through fluid collection device 12 via the fluid storage container 14. As the fluid is drained from the chamber, the fluid may travel through the first section of conduit to the fluid storage container where it may be retained. Fluid, such as urine, may be drained from the fluid collection device 12 using the portable vacuum source 16.
[0065] In some embodiments, the portable vacuum source 16 may be disposed in or on the fluid collection device 12. In such examples, the conduit 17 may extend from the fluid collection device and attach to the portable vacuum source 16 at a first point therein. An additional conduit 17 may attach to the portable vacuum source 16 at a second point thereon and may extend out of the fluid collection device 12, and may attach to the fluid storage
container 14. Accordingly, a vacuum (e.g., suction) may be drawn through fluid collection device 12 via the fluid storage container 14.
[0066] The portable vacuum source 16 may include one or more of a manual vacuum pump, and electric vacuum pump, a diaphragm pump, a centrifugal pump, a displacement pump, a magnetically driven pump, a peristaltic pump, or any pump configured to produce a vacuum. The portable vacuum source 16 may provide a vacuum or suction to remove fluid from the fluid collection member of the fluid collection device 12. In some embodiments, the portable vacuum source 16 may be powered by one or more of a power cord (e.g., connected to a power socket), one or more batteries, or even manual power (e.g., a hand operated vacuum pump). In examples, the portable vacuum source 16 may be sized and shaped to fit outside of, on, or within the fluid collection device 12. For example, the portable vacuum source 16 may include one or more miniaturized pumps or one or more micro pumps. The portable vacuum sources 16 disclosed herein may include one or more of a switch, a button, a plug, a remote, or any other device suitable to activate the portable vacuum source 16. It should be understood that the portable vacuum sources 16 disclosed herein may provide a portable means of providing a suction or vacuum that allows use of the devices and systems herein outside of hospital or care facility environments where vacuum lines are plumbed into patient rooms or large (e.g., larger or heavier than a patient can readily carry) vacuum sources are located. For example, a portable vacuum source may be small and light enough to be carried by a user (e.g., patient) or aid (e.g., nurse) during transportation of the user.
[0067] FIG. 6 is a flow diagram of a method 600 to collect fluid, according to an embodiment. The method 600 may utilize any of the fluid collections described herein. In some embodiments, the method 600 includes an act 605 of inserting a penis of user at least partially through an opening in a urine collection device and into a chamber of the urine collection device. The opening and the chamber may be at least partially defined by a fluid impermeable barrier of the urine collection device. The method 600 also may include an act 610 of receiving urine discharged by the user in the chamber. The method 600 also may include an act 615 of withdrawing the urine from the chamber through a tube having an inlet that is movable within the chamber and through an outlet in the urine collection device. [0068] In some embodiments of the method 600, the fluid impermeable barrier includes a proximal region defining the opening, a distal region opposite to the proximal region, a first region including the outlet, and a second region opposite to the first region. In these and other embodiments, the opening may be positioned between the first region and the
second region, and the may extend from the outlet to the tube inlet positioned at least proximate to the second region of the fluid impermeable barrier. In these and other embodiments, the proximal region and the distal region may narrow from second region towards the first region. In some embodiments of the method 600, the proximal region includes an inner surface partially defining the chamber and sloping between the first region to the second region such that the second region has a greater depth between the proximal region and the distal region than the first region and the urine discharged in the chamber flows to the second region.
[0069] In some embodiments, the method 600 also includes an act of biasing the tube inlet to a low point in the chamber at least proximate to the second region with a weight secured to the tube proximate to the tube inlet.
[0070] In some embodiments, the act 605 includes inserting the penis of the user through a rim extending distally into the chamber from the proximal region to the chamber such that the rim is spaced inward from the inner surface of the fluid impermeable barrier defining the chamber, with the rim extending around all of the opening and forming a seal against at least a portion of the penis. In these and other embodiments, the rim may form a generally frustoconical shape that narrows as the rim extends inward to the chamber.
[0071] In some embodiments, the act 605 may include inserting the penis of the user through a rim extending distally at least partially into the chamber from the proximal region to the chamber such that the rim is spaced inward from the inner surface of the fluid impermeable barrier defining the chamber. In these and other embodiments, the rim may extend around all of the opening and form a seal against at least a portion of the penis, with the tube inlet being disposed in the chamber at least proximate to the rim. In some embodiments of the method 600, the urine collection device includes a track disposed in the chamber between the rim and the inner surface of the fluid impermeable barrier, and the tube inlet may move at least partially within the track to withdraw the urine. In these and other embodiments, the method 600 may include an act of biasing the tube inlet to a low point in the chamber with a weight secured to the tube proximate to the tube inlet.
[0072] Acts of the method 600 are for illustrative purposes. For example, the acts of the method 600 may be performed in different orders, split into multiple acts, modified, supplemented, or combined. Any of the acts of the method 600 may include using any of the fluid collection devices or systems disclosed herein.
[0073] As used herein, the term “about” or “substantially” refers to an allowable variance of the term modified by “about” by ±10% or ±5%. Further, the terms “less than,”
“or less,” “greater than”, “more than,” or “or more” include as an endpoint, the value that is modified by the terms “less than,” “or less,” “greater than,” “more than,” or “or more.” [0074] While various aspects and embodiments have been disclosed herein, other aspects and embodiments are contemplated. The various aspects and embodiment disclosed herein are for purposes of illustration and are not intended to be limiting.
Claims
1. A urine collection device, comprising: a fluid impermeable barrier having a proximal region, a distal region, and an inner surface defining a chamber therein; a rim extending distally from the proximal region into the chamber and at least partially defining an opening sized to receive at least a portion of a penis therethrough, at least some of the rim being spaced inwardly from the inner surface of the fluid impermeable barrier defining the chamber and sized and configured to form a seal against at least a portion of the penis, wherein the chamber is positioned to receive at least some of the penis received through the opening in the proximal region; and an outlet in fluid communication with the chamber.
2. The urine collection device of claim 1, wherein the rim extends around all of the opening effective to form a channel extending through the proximal region to the chamber, the rim being sized to form a seal against the penis when the penis is disposed in the channel with at least some of the penis extending through the channel into the chamber.
3. The urine collection device of claim 2, wherein the rim forms a generally frustoconical shape that narrows as the rim extends inward to the chamber.
4. The urine collection device of claim 3, further comprising a tube disposed in the chamber and secured to the outlet such that the tube provides fluid communication between the chamber and the outlet, wherein the outlet is disposed at the distal region of the fluid impermeable barrier.
5. The urine collection device of claim 4, wherein the tube includes a tube inlet disposed in the chamber at least proximate to the rim.
6. The urine collection device of claim 5, further comprising a track disposed in the chamber between the rim and the inner surface of the fluid impermeable barrier, wherein the tube inlet is disposed at least partially within the track.
7. The urine collection device of either of claims 5 or 6, further comprising a weight secured to the tube proximate to the tube inlet, wherein at least some of the tube is movable within the chamber and the weight biases the tube inlet to a low point in the chamber.
8. The urine collection device of either of claims 1 or 2, wherein: the proximal region has a generally frustoconical shape that widens as the proximal region extends distally towards the distal region; the distal region has a generally frustoconical shape that widens as the distal region extends proximally towards the proximal region, the distal region being secured to the proximal region such that the inner surface of the fluid impermeable barrier slopes to include a maximum width of the chamber substantially between the proximal region and the distal region.
9. The urine collection device of claim 8, wherein the proximal region includes a fluid impermeable foam material.
10. The urine collection device of either of claims 8 or 9, wherein the outlet is disposed at least proximate to the maximum width of the chamber.
11. The urine collection device of any of claims 7-9, further comprising a tube disposed in the chamber and secured to the outlet such that the tube provides fluid communication between the chamber and the outlet, wherein the outlet is disposed at the distal region of the fluid impermeable barrier.
12. The urine collection device of claim 11 , wherein the tube includes a tube inlet disposed in the chamber at least proximate to the rim.
13. The urine collection device of claim 12, further comprising a weight secured to the tube proximate to the tube inlet, wherein at least some of the tube is movable within the chamber and the weight biases the tube inlet to a low point in the chamber.
14. The urine collection device of any of claims 1-13, further comprising one or more straps secured or securable to the fluid impermeable barrier and configured to secure the urine collection device to a user.
15. The urine collection device of any of claims 1-14, further comprising a transparent window on the distal region.
16. A urine collection device, comprising: a fluid impermeable barrier defining a chamber and an opening in fluid communication with the chamber, the opening being sized to receive at least a portion of a penis therethrough and the chamber positioned and sized to receive at least some of the penis received through the opening; an outlet; and a tube disposed in the chamber and secured to the outlet such that the tube provides fluid communication between the chamber and the outlet, the tube having a tube outlet secured to the outlet of the urine collection device and a tube inlet movable within the chamber while the tube outlet remains in a fixed location.
17. The urine collection device of claim 16, wherein the fluid impermeable barrier includes a proximal region defining the opening, a distal region opposite to the proximal region, a first region including the outlet, and a second region opposite to the first region, the opening being positioned between the first region and the second region, wherein the tube extends from the outlet to the tube inlet positioned at least proximate to the second region of the fluid impermeable barrier.
18. The urine collection device of claim 17, wherein the proximal region and the distal region narrow from second region towards the first region.
19. The urine collection device of either of claims 17 or 18, wherein the proximal region includes an inner surface partially defining the chamber and sloping between the first region to the second region such that the second region has a greater depth between the proximal region and the distal region than the first region.
20. The urine collection device of any of claims 17-19, further comprising a weight secured to the tube proximate to the tube inlet, wherein at least some of the tube is movable within the chamber and the weight biases the tube inlet to a low point in the chamber at least proximate to the second region.
21. The urine collection device of any of claims 17-20, further comprising a rim extending distally at least partially into the chamber from the proximal region to the chamber such that the rim is spaced inwardly from the inner surface of the fluid impermeable barrier defining the chamber, the rim extending around all of the opening and sized to form a seal against at least a portion of the penis.
22. The urine collection device of claim 21, wherein the rim forms a generally frustoconical shape that narrows as the rim extends inward from the opening.
23. The urine collection device of claim 16, further comprising a rim extending inward from the opening at least partially into the chamber such that the rim is spaced inwardly from the inner surface of the fluid impermeable barrier defining the chamber, the rim extending around all of the opening and sized to form a seal against at least a portion of the penis, wherein the tube inlet is disposed in the chamber at least proximate to the rim.
24. The urine collection device of claim 23, further comprising a track disposed in the chamber between the rim and the inner surface of the fluid impermeable barrier, wherein the tube inlet is disposed at least partially within the track.
25. The urine collection device of either of claims 23 or 24, further comprising a weight secured to the tube proximate to the tube inlet, wherein at least some of the tube is movable within the chamber and the weight biases the tube inlet to a low point in the chamber.
26. The urine collection device of claim 16, wherein: the proximal region has a generally frustoconical shape that widens as the proximal region extends distally towards the distal region; and the distal region has a generally frustoconical shape that widens as the distal region extends proximally towards the proximal region, the distal region being secured to the proximal region such that the inner surface of the fluid impermeable barrier slopes to include a maximum width of the chamber substantially between the proximal region and the distal region.
27. The urine collection device of claim 26, wherein the proximal region includes a fluid impermeable foam material.
28. The urine collection device of either of claims 26 or 27, wherein the outlet is disposed at least proximate to the maximum width of the chamber.
29. The urine collection device of any of claims 16-28, further comprising one or more straps secured or securable to the fluid impermeable barrier and configured to secure the urine collection device to a user.
30. The urine collection device of any of claims 16-29, further comprising a transparent window on the distal region.
31. A urine collection device, comprising: a fluid impermeable barrier having a proximal region, an opening in the proximal region sized to receive at least a portion of a penis therethrough, a distal region, and an inner surface defining a chamber having a proximal shape that widens in the proximal region as the proximal region extends distally towards the distal region and a distal shape in the distal region that widens as the distal region extends proximally towards the proximal region such that the inner surface of the fluid impermeable barrier slopes to include a maximum width of the chamber substantially between the proximal region and the distal region; and an outlet in fluid communication with the chamber and disposed at least proximate to the maximum width of the chamber.
32. The urine collection device of claim 31, wherein the proximal region includes a fluid impermeable foam material.
33. The urine collection device of claim 32, wherein the outlet is formed in the proximal region and includes the fluid impermeable foam material.
34. The urine collection device of any of claims 32 or 33, wherein the proximal region includes a rim extending distally from the proximal region into the chamber and defining the opening effective to form a channel extending through the proximal region to the chamber, the rim being spaced inward from at least some of the maximum width of the chamber.
35. The urine collection device of claim 31, wherein the proximal region includes a silicone material that is flexible.
36. The urine collection device of claim 35, wherein the outlet is formed in the proximal region and includes the silicone material.
37. The urine collection device of any of claims 31-36, wherein: the proximal region includes a generally frustoconical or semi-spherical shape that widens as the proximal region extends distally towards the distal region; and the distal region includes a generally frustoconical shape or semi-spherical shape that widens as the distal region extends proximally towards the proximal region.
38. A system, comprising: the urine collection device of any one of claims 1-37; a vacuum source configured to apply a vacuum force; a fluid storage container; and at least one conduit connected to the outlet and in fluid communication with the vacuum source and the fluid storage container.
39. A method of collecting urine, the method comprising: inserting a penis of a user at least partially through an opening in a urine collection device and into a chamber of the urine collection device, the opening and the chamber being at least partially defined by a fluid impermeable barrier of the urine collection device; receiving urine discharged by the user in the chamber; withdrawing the urine from the chamber through a tube having an inlet that is movable within the chamber and through an outlet in the urine collection device.
40. The method of claim 39, wherein the fluid impermeable barrier includes a proximal region defining the opening, a distal region opposite to the proximal region, a first region including the outlet, and a second region opposite to the first region, the opening being positioned between the first region and the second region, wherein the tube extends from the outlet to the tube inlet positioned at least proximate to the second region of the fluid impermeable barrier.
41. The method of claim 40, wherein the proximal region and the distal region narrow from second region towards the first region.
42. The method of either of claims 40 or 41, wherein the proximal region includes an inner surface partially defining the chamber and sloping between the first region to the second region such that the second region has a greater depth between the proximal region and the distal region than the first region and the urine discharged in the chamber flows to the second region.
43. The method of any of claims 40-42, further comprising biasing the tube inlet to a low point in the chamber at least proximate to the second region with a weight secured to the tube proximate to the tube inlet.
44. The method of any of claims 40-43, wherein inserting a penis of a user at least partially through an opening in a urine collection device and into a chamber of the urine collection device includes inserting the penis of the user through a rim extending distally into the chamber from the proximal region to the chamber such that the rim is spaced inwardly from the inner surface of the fluid impermeable barrier defining the chamber, the rim extending around all of the opening and forming a seal against at least a portion of the penis.
45. The method of claim 44, wherein the rim forms a generally frustoconical shape that narrows as the rim extends inward to the chamber.
46. The method of claim 39, wherein inserting a penis of user at least partially through an opening in a urine collection device and into a chamber of the urine collection device includes inserting the penis of the user through a rim extending distally at least partially into the chamber from the proximal region to the chamber such that the rim is spaced inwardly from the inner surface of the fluid impermeable barrier defining the chamber, the rim extending around all of the opening and forming a seal against at least a portion of the penis, wherein the tube inlet is disposed in the chamber at least proximate to the rim.
47. The method of claim 46, wherein the urine collection device includes a track disposed in the chamber between the rim and the inner surface of the fluid impermeable barrier, wherein the tube inlet moves at least partially within the track to withdraw the urine.
48. The method of either of claims 46 or 47, further comprising biasing the tube inlet to a low point in the chamber with a weight secured to the tube proximate to the tube inlet.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/US2023/077205 WO2025085079A1 (en) | 2023-10-18 | 2023-10-18 | Male urine collection devices, related systems and methods |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/US2023/077205 WO2025085079A1 (en) | 2023-10-18 | 2023-10-18 | Male urine collection devices, related systems and methods |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2025085079A1 true WO2025085079A1 (en) | 2025-04-24 |
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ID=88793102
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/US2023/077205 Pending WO2025085079A1 (en) | 2023-10-18 | 2023-10-18 | Male urine collection devices, related systems and methods |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2025085079A1 (en) |
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| EP0220962A1 (en) * | 1985-10-28 | 1987-05-06 | Negretti Aviation Limited | Urination facility |
| US20050131361A1 (en) * | 2002-09-18 | 2005-06-16 | Mark Miskie | Receptacle for a male incontinence device |
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